Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208624
Company: ABBVIE
Company: ABBVIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VIEKIRA XR | DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR | EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/22/2016 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208624s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208624Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208624Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/06/2019 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208624s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208624Orig1s008ltr.pdf | |
07/23/2018 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208624s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208624Orig1s006ltr.pdf | |
11/09/2017 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624Orig1s005ltr.pdf | |
03/22/2017 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208624Orig1s001,208624Orig1s003ltr.pdf | |
02/14/2017 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208624Orig1s002ltr.pdf | |
03/22/2017 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208624Orig1s001,208624Orig1s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/06/2019 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208624s008lbl.pdf | |
07/23/2018 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208624s006lbl.pdf | |
11/09/2017 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624Orig1s005ltr.pdf | |
03/22/2017 | SUPPL-3 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624s001s003lbl.pdf | |
03/22/2017 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624s001s003lbl.pdf | |
03/22/2017 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624s001s003lbl.pdf | |
02/14/2017 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624s002lbl.pdf | |
07/22/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208624s000lbl.pdf |